Kornimate/medical-research-clean huggingface dataset:
comparing modified meek and mesh techniques

Conditions: Third Degree Burns

Summary: this is a clinical trial study that compare two plastic surgery techniques in patients with third degree of burning and both techniques are used in all patients but in different areas of burning sites of the patients.

patient registration: the patients are registered after careful examination for third degree of burning and based on the need for skin grafting and of course a written consent were acquired. excluded patients were those with an infected lesion or those who did not allow us to enter them into the study. progression of the treatment results of both techniques were visited by the surgeon regularly. at the end of the study the data were checked with other similar studies. the acquired data were compared to other external data sources via medical records. there were two standard operating techniques: modified meek skin grafting technique and mesh skin grafting technique. the data was analyzed by chi-square and t-test.

Eligibility criteria:
inclusion criteria: * third degree of burning exclusion criteria: * infected lesions
patient and caregiver psychological functioning following neuro-icu admission: a prospective investigation

Conditions: Intensive Care Neurological Disorder

Summary: the current study has the following objectives: 1. to determine predictors of time 2 and 3 (3 and 6 months post-icu admission) depression, ptsd, satisfaction with life and quality of life in both patients and caregivers, after controlling for injury severity and impairment. 2. to determine factors associated with patient and caregiver satisfaction with medical care at time 2 and time 3. the investigators would thus be able to identify the best time point for intervention delivery, intervention targets, and risk factors for chronic psychological distress.


Eligibility criteria:
inclusion criteria for patients: 1. 18 years of age and older 2. english fluency and literacy 3. admitted to the neuro-icu inclusion criteria for family caregivers: 1. 18 years of age and older 2. english fluency and literacy 3. family member of patient who is identified by patient as the primary caregiver exclusion criteria: 1. patients who cannot complete questionnaires due to their medical condition, and are anticipated to not be able to complete questionnaires at any of the future time points, due to permanent impairment. 2. patients who lack decision-making capacity as determined by their clinical team 3. patients who are comfort measures only (cmo)
nitrate and brain insulin-sensitivity

Conditions: Nitrate; Brain Insulin-sensitivity; Vascular Function

Summary: disturbances in brain insulin-sensitivity are not only observed in abdominal obesity and type 2 diabetes mellitus (t2d), but also during brain aging and in dementia. inorganic nitrate may improve brain insulin-sensitivity, which can be quantified by measuring the gray-matter cerebral blood flow (cbf) response to intranasally administered insulin, through beneficial effects on brain vascular function. therefore, we now hypothesize that inorganic nitrate, which can be found in several vegetables such as beetroot, improves brain insulin-sensitivity, as assessed by the gray-matter cbf response to intranasally administered insulin, in abdominally obese men.


Eligibility criteria:
inclusion criteria: * men; * aged between 18 - 60 years; * waist circumference \> 102 cm (abdominally obese); * fasting plasma glucose ≤ 7.0 mmol/l; * fasting serum total cholesterol ≤ 8.0 mmol/l; * systolic blood pressure \< 160 mmhg and diastolic blood pressure \< 100 mmhg; * stable body weight (weight gain or loss \< 3 kg in the past three months); * willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study; * willingness not to use antibacterial mouth wash or toothpaste, chewing-gum and tongue-scraping a week before the study; * no difficult venipuncture as evidenced during the screening visit. exclusion criteria: * women; * left-handedness; * current smoker, or smoking cessation \< 12 months; * diabetic patients; * familial hypercholesterolemia; * abuse of drugs; * more than 3 alcoholic consumptions per day; * use of products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators; * use medication to treat blood pressure, lipid or glucose metabolism; * pharmacological treatment advised based on the dutch general practitioners' association (nhg) for cardiovascular risk management; * use of an investigational product within another biomedical intervention trial within the previous 1-month; * severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis; * active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident; * specific contra-indications for mri imaging, including pacemakers, surgical clips/material in body, metal splinters in eye, claustrophobia, or tattoos in the facial area, such as permanent make-up.
effect of music and mindfulness meditation

Conditions: Anxiety

Summary: the purpose of the study is to explore the effect of music and mindfulness meditation on anxiety and mindful interoception in undergraduate music students.


Eligibility criteria:
inclusion criteria: * participants must be undergraduate college students majoring in a music degree. * participants must self-report feeling general anxiety at a level of 7/10 recently. * participants must be proficient english-readers and -speakers and be full-time enrolled students. * students of any gender and race/ethnic group may be included. * participants must be novice meditators, having fewer than 10 total meditation experiences. * students of any year will be accepted if they are considered undergraduate students by the university. exclusion criteria: * self-reporting feeling general anxiety below a 7/10 recently. * having more than 10 total meditation experiences.
remdesivir-hu clinical study and severe covid-19 patients

Conditions: SARS-CoV-2 Infection

Summary: this is a phase 3, open-label, multi-center, interventional safety study of rem therapy in participants 12 years of age or older with covid-19, pneumonia and oxygen supplementation.


Eligibility criteria:
inclusion criteria: * males or females aged 12yrs and older with body weight at least 40kg * hospitalized with covid-19 confirmed by pcr and/or covid-19 typical symptoms with pneumonia: ▪ in case of no confirmed pcr test result available at screening, typical symptoms can also apply * requiring supplemental oxygen at screening ▪ at the discretion of the investigator, any form of o2 support can apply * do not have access to veklury treatment ▪ patient may be under other treatment against covid-19 (except for chloroquine/hydroxychloroquine) * willing and able to provide valid written informed consent prior to performing study procedures (for those \<18yrs of age, parental consent and patient assent is required). for an unconscious or comatose patient written informed consent given by next of kin or a legal representative is also accepted. if none of the above consents are available the investigator can enroll the patient as described in 21 cfr 50.24 (involving emergency research). exclusion criteria: known liver disease, hepatic impairment and/or alanine transaminase (alt) or aspartate transaminase (ast) ≥ 5 times the upper limit of normal * known severe renal disease (including patients receiving hemodialysis or hemofiltration) and/or estimated glomerular filtration rate (egfr) \< 30 ml/min. * pregnancy or breast feeding at the discretion of the investigator * anticipated discharge from the hospital or transfer to another hospital which is not a study site within 120 hours * know allergy to any anti-viral medication * hypersensitivity to the active substance(s) or to any of the excipients * current (or 48 hours prior) treatment with chloroquine/hydroxychloroquine other investigationsl treatment up to 2x the "emptying" time of treatment, or if this is not known for 60 days, except in the case of a favipiravir study. in case of the clinical trial of favipiravir the petinents can be enrolled in the study if afterthe end of study / early termination visit. * any medical condition that the examining physician deems unsuitable for the patient to participate in the study.

Keywords: sars-cov-2, covid-19
effects of the bifidobacterium longum bl21 on bmi, metabolic indicators, and gut microbiota in overweight/obese adults

Conditions: Overweight/Obese Adults

Summary: the goal of this study is to investigate the effects of bifidobacterium longum subspecies bl21 on bmi, metabolic indicators, and changes in gut microenvironment microbiota in overweight/obese adults. the blood, urine, and feces samples of the subjects need to be collected at 0,4 and 8 week and promptly tested in the laboratory. during the intervention period, all groups of subjects were required to take the corresponding products daily and record adverse reactions.

the goal of this study is to investigate the effects of bifidobacterium longum subspecies bl21 on bmi, metabolic indicators, and changes in gut microenvironment microbiota in overweight/obese adults. randomized grouping was used to provide probiotic bl21 or placebo intervention. the total duration of the study is 8 weeks, including 8 weeks (1-8 weeks) of intervention expectations. the subjects were followed up at weeks 2 and 6, and sampled at weeks 0, 4, and 8. after the intervention during the follow-up period, blood, urine, and feces samples of the subjects need to be collected and promptly tested in the laboratory. during the intervention period, all groups of subjects were required to take the corresponding products daily and record adverse reactions.

Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) ≥ 24kg/m2 indicates overweight, and bmi ≥ 28kg/m2 indicates obesity; 2. willing to take the test formulation daily during the study period; 3. subjects who understand clinical research and commit to complying with research requirements and procedures. exclusion criteria: 1. patients with serious chronic diseases (heart, liver, kidney, hematopoietic system, tumor and other serious diseases, mental disease and organ surgery history, diabetes, etc.) and complications; 2. patients with severe allergies and immune deficiencies; 3. pregnant, breastfeeding, or expectant women during the study period 4. patients with a clear history of gastrointestinal diseases (ulcers, irritable bowel syndrome, etc.); 5. have a history of intervention with lipid-lowering drugs or health products within the past 2 months; 6. individuals who have used antibiotics within the past two weeks; 7. failure to consume the test sample as required, or failure to follow up on time, resulting in uncertain efficacy 8. subjects deemed unsuitable by other researchers to participate.
achieving normal glucose in hospital settings

Conditions: Dysglycaemia

Summary: the main objective of this study is to evaluate the efficacy and safety of 24 hours of closed-loop glucose control compared with standard diabetes treatment, in patients with type 2 diabetes treated by non-insulin glucose-lowering medications. this group is being studied as it is representative of patients with glucose dysregulation.

algorithm driven closed-loop enables automated subcutaneous delivery of insulin in response to real-time continuous glucose sensor readings. our studies to date have assessed the safety and efficacy of closed-loop insulin delivery in patients with type 1 diabetes in a controlled setting. for patients with type 2 diabetes treated by diet or non-insulin glucose-lowering medications alone, an episode of acute illness may result in elevated glucose levels necessitating initiation of insulin replacement therapy to optimise glycaemic control. insulin may also be required in patients with no prior history of diabetes, presenting with 'stress hyperglycaemia'. closed-loop systems may be of benefit in such insulin-naive patients in whom the optimal dosing regimen is difficult to establish, and may provide a safer method of insulin delivery with the added benefit of continuous monitoring of glucose levels on general hospital wards, thus minimising the likelihood of hyper- and hypoglycaemic events and their known associated worse outcomes. the study has an open-label, randomised, two-period crossover design. participants will be randomised to undergo two 24-hour studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm (intervention) or by patients' usual non-insulin glucose-lowering diabetes treatment regimen (control). a continuous glucose sensor will be inserted on arrival for each visit. participants will consume regular meals (matched on both visits) and carry out daily activities mimicking those occurring in an inpatient setting. stable glucose isotopes will be administered on the two study occasions to collect data for modeling of glucose turnover around meals and during the overnight period.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * type 2 diabetes for at least 1 year as defined by who * treatment with glucose-lowering medication(s) (including exenatide) for at least 6 mths * hba1c between 7.0% and 10.0% inclusive (measured within past 3 mths) exclusion criteria: * autoimmune type 1 diabetes * type 2 diabetes treated with insulin * type 2 diabetes treated with diet control alone * known or suspected allergy against insulin * proliferative retinopathy * current or planned pregnancy or breast feeding * any physical or psychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by the study clinician

Keywords: dysglycemia diabetes closed loop insulin delivery
phase ii evaluation of gemcitabine- rituximab-oxaliplatin combination (groc) in relapsed aggressive lymphomas

Conditions: Refractory Aggressive Non-Hodgkin's Lymphoma; Relapsing Aggressive Non-Hodgkin's Lymphoma

Summary: study proposal: other drugs where synergy with gemcitabine has been observed are cisplatinum, taxol, taxotere, etoposide and alkylating agents. however in view of oxaliplatin's superior activity as a single agent against lymphoma, the combination of gemcitabine with oxaliplatin is more attractive and should be explored in this group of disorders. based on these data and considering the advantage of its favorable toxicity profile, we propose a phase ii study in patients with either refractory or relapsing aggressive non-hodgkin's lymphomas including peripheral t-cell lymphomas which are known to have a poor outcome when compared with equivalent aggressive b-cell lymphomas.


Eligibility criteria:
inclusion criteria: * patients with refractory or relapsed aggressive non-hodgkin's lymphoma. the definition of refractory includes patients who either did not respond to prior therapy or those whose best response was a pr after at least 4 courses of chemotherapy. aggressive histologies include follicular large cell, diffuse large cell, peripheral t cell, transformed lymphomas, lymphoblastic lymphomas, burkitt and burkitt like lymphomas. * histologic or cytological confirmation of refractory or relapsed aggressive non-hodgkin's lymphoma is desirable but not mandatory and will be left to the discretion of the investigator. * must have measurable or evaluable disease. * no more than 4 previous regimens of chemotherapy will be allowed, including stem cell or bone marrow transplant. * patients must be more than 18 years old. * no evidence of grade 3 or more neurosensory or neuromotor dysfunction (see appendix- toxicity criteria) * written consent * those patients who have previously received a platinum or nucleoside analogue-containing regimen are eligible. * patients who are candidates for stem cell or marrow transplant will be included exclusion criteria: * patients with a previous or concurrent history of cancer with the exception of: 1-treated carcinoma in situ of cervix or breast. 2- treated squamous or basal cell skin cancer, or 3- any other surgically cured malignancy from which the patient has been disease free for at least 5 years. * hiv positive patients and those with hepatitis b or c will be excluded from this protocol. * patients with severe neuropathy will be excluded. * chemotherapy or radiotherapy within the previous 3 weeks prior to entering study.
efficacy, safety and tolerability of afq056 in fragile x patients

Conditions: Fragile X Syndrome

Summary: this study will evaluate the safety, tolerability and efficacy of multiple doses of afq056 in patients with fragile x syndrome. the dose range will be 50 to 150 mg b.i.d. the primary read-out of efficacy is reduction in aberrant-behavior checklist score.


Eligibility criteria:
inclusion criteria: * male, non-smoking patients between 18 and 35 years of age (both inclusive). * patients with fmr1 full mutation (\> 200 cgg repeats) * patients with a clinical global impression severity score (cgi-s) of \> 4 (moderately ill) * patients with a score of \>20 in the abc-c scale (at screening) * patients with a mental age of ≥ 48 months as measured by the stanford-binet test exclusion criteria: * patients with dsm-iv diagnosis of schizophrenia, history and/or presence of psychosis, confusional states and/or repeated hallucinations. * patients with a history of seizures in the past 5 years without any therapeutic treatment controlling the disorders. * patients under stable anti-convulsant therapies that experienced seizures in the 2 years prior to randomization * patients with ecg abnormalities, autonomic dysfunctions, bronchospastic diseases, drug or atopic allergy * any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs * patients using (or have used within four weeks before randomization) concomitant medications that are potent inhibitors of cyp3a4 (e.g., ketoconazole, ritonavir, etc.) other protocol-defined inclusion/exclusion criteria may apply.

Keywords: fragile x syndrome, adults, efficacy
effect of sodium bicarbonate on prevention of acute kidney injury in high risk patients undergoing off-pump coronary artery bypass (opcab)

Conditions: Acute Kidney Injury

Summary: in this single-site, randomized, controlled and double-blind clinical trial, the investigators evaluate the effect of sodium bicarbonate on prevention of acute kidney injury in high risk patients undergoing off pump coronary bypass surgery.


Eligibility criteria:
inclusion criteria: * patients older than 20 years * scheduled for elective coronary artery bypass grafting. * preoperative estimated glomerular filtration rate (egfr) : 30 \~ 89 % * lvef \< 35% * nyha class iii or iv * age \> 70 * dm * reoperation exclusion criteria: * acute renal impairment * patients who receive dialysis * patients who receive steroid ( \> 10mg/day prednisolon or equivalent) * hemo-alkalosis * hypernatremia * pulmonary edema * hemoglobin \< 10 mg/dl

Keywords: sodium bicarbonate acute kidney injury opcab
a study to evaluate the quality of life in male and female adult participants with severe asthma treated with dupilumab in a real-world setting

Conditions: Asthma

Summary: primary objective: - to describe dupilumab health-related quality of life (hrqol) effectiveness at 52 weeks compared to baseline. secondary objectives: * to describe dupilumab hrqol effectiveness at 12 and 24 weeks compared to baseline. * to assess the safety during the year of treatment in a real-world setting.


Eligibility criteria:
inclusion criteria: * participant must be at least 18 years of age inclusive, at the time of signing the informed consent. * participant for whom decision of initiation and prescription of dupilumab (dupixent®) for the severe uncontrolled asthma indication was made by the investigator within four weeks before the inclusion in the study. oral corticosteroid (ocs) or non-ocs-dependent patient could be included. * participant for whom st. george's respiratory questionnaire (sgrq) score is available within the last 4 weeks prior to dupilumab initiation. sgrq score could be collected at baseline visit for participants who have not yet started dupilumab. * capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. exclusion criteria: * participant below 18 years of age. - participant participating in a clinical trial at the time of enrolment. * participant under guardianship, trusteeship or under judicial protection. the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
effectiveness of nurse-led family intervention on stress, engagement with patient's care and satisfaction among primary caregivers of chronic liver disease patients admitted in high dependency unit of ilbs, new delhi

Conditions: Family Members of the Patients

Summary: quasi experimental study to check the effectiveness of nurse-led family intervention on stress, engagement with patient care and satisfaction among primary caregivers of chronic liver disease patients admitted in high depency unit ilbs, two group pre test post test design non randomisation with the nurse-led family intervention with the sample size of 80 using purposive sampling technique and having independent variable as nurse-led family intervention and dependent variables are stress, engagement with patient care and satisfaction and these variables are assesed by using kingston caregivers scale(kcss) caregiver health engagement scale (chew-s)and one knowledge questionnaire based on engagement and satisfaction scale

study having different inclusion and exclusion for criteria cld patients and caregiver sof patint's admitted in hdu inclusion criteria of primary caregivers between the age group of 18-65years understand hindi and english duration of hjospitalization should be more than 6 hours exclusion criteria is primary are givers who cannot understand hindi or english and age more than 65 years of age , craegivers of patients who are having disease other than cld and those who are not willing to participate inclusion for criteria cld patients decompensated cld patients , understand hindi and english , duration of hospitalization more than 6 hours , patient is concious and in semi concious state and patient with hepatic encephlopathy

Eligibility criteria:
inclusion criteria:between age group of 18-65 years * primary caregivers of cld patient's understand hindi and english duration of hospitalization more than 6 hours exclusion criteria: * primary caregivers who cannot understand hindi and english age more than 65 years of age caregivers of patient's who are other than cld not willing to participate